Actively Recruiting
Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Led by Children's Hospital of Fudan University · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to collect clinical data from children aged 2 to under 18 years who have giant coronary artery aneurysms after Kawasaki disease and are receiving rivaroxaban treatment. The study aims to analyze rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms to support population pharmacokinetic and pharmacodynamic analysis. Participants will be treated with rivaroxaban as an anticoagulant combined with an antiplatelet drug for long-term blood clot prevention. The dosing regimen is optimized based on a model, and rivaroxaban plasma concentration and calibrated anti-FXa activity will be measured for clinical monitoring. Treatment and monitoring will continue for six months from the start of rivaroxaban therapy. During the study, scheduled blood samples will be collected from baseline to six months after starting rivaroxaban, including at the first hospitalization, to measure drug levels and anti-FXa activity. Researchers will also observe the occurrence of new coronary artery thrombosis and any major or clinically relevant bleeding events. The total participation duration covers this six-month monitoring period.
CONDITIONS
Brief Title
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years to under 18 years
- Diagnosis of giant coronary artery aneurysm(s) after acute Kawasaki disease, confirmed by 2D echocardiography with Z-score 210 or coronary artery internal diameter 28mm
- Recommended anticoagulant and antiplatelet therapy for thromboprophylaxis for the next 6 months
You will not qualify if you...
- Presence of active bleeding or bleeding risk that contraindicates anticoagulant therapy
- Hypersensitivity or contraindications listed in local labeling for the treatment
- Participation in other clinical drug trials simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants who receive rivaroxaban and antiplatelet therapy are monitored for drug plasma concentration, anti-FXa activity, and clinical outcomes related to thrombosis and bleeding.
Scheduled sampling at the first hospitalization and additional clinical monitoring visits over 6 months
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
F
Fang Liu, MD
G
Guangan Dai, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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